IS : 6058 - 1970 Reaffirmed 1996 )) ((Reaffirmed 2012 Indian Standard SPECIFICATION FOR RUBBER COMPONENTS FOR TRANSFUSION FLUID BOTTLES ( First Reprint SEPTEMBER 1997 ) UDC 666.171 : 615.38 : 678.4.06 0 Copyright 1971 BUREAU MANAK OF BHAVAN. INDIAN 9 BAHADUR DELHI STANDARDS SHAH 110002 ZAFAR MARG NEW Gr 4 Oclober 1971 IS : 6058- 1970 Indian Standard SPECIFICATION FOR RUBBER COMPONENTS FOR TRANSFUSION FLUID BOTTLES Rubber Products Sectional Committee, CDC 6 Chairman DR D. BANERJEE Representing National Rubber Manufacturers Ltd, Calcutta; and Association of Rubber Manufacturers in India, Calcutta National Test House, Calcutta The Alkali & Chemical Calcutta Corporation of India Ltd, Members SHRI S. K. Bosr: SHRI A. GROSH ( Ahernate ) SRRI D. K. CHATTERJEE DR S. K. RAY ( Alternate ) Ministry of Defence ( DGI )_: SHRI B. H. DALAL SHRI M. KUMARAN ( Alternate ) SRRX DALIP KUMAR Ministry of Railways Export Inspection Council of India, Calcutta SRRI G. C. DE SHRI P. K. CRATTERJEE ( Altcrnatc ) Dire&orate General of Supplies & Disposals SHRI G. M. GADRE Hindustan Steel Ltd, Ranchi SHRI G. C. JAIN SHRI LALIT MORAN JAMNADAS Cosmos India Rubber Works Pvt Ltd, Bombay SHRI PULIN L. KINARIWALA ( Alternate ) DR P. JOHN JACOB The Rubber Research Institute of India. Kottavam SHRI S. V. LATRIA Lathia Rubbers Manufacturing Co Ltd, `Bombay SRRI D. P. LATHIA ( Alternate ) Indian Rubber Industries Association, Bombay; and DR K. N. MODAK Indian Rubber Manufacturers' Research Association, Bombay SHRI K. R. SENGUPTA Indian Rubber Industries Association, Bombay Dunlop India Ltd, Calcutta SHRI P. N. S. MYER ( Alternate, ) Bata Shoe Co Pvt Ltd, Calcutta SHRI S. C. NANDY Synthetics and Chemicals Ltd. Bombay SHRI M. M. PATEL Indi~o~~a~ation Ltd ( Marketing Division ), SHRI K. RAJGOPAUL DR A. SEETHARAMIAR DR N. V. C. RAO ( Alternate ) Directorate General of Technical Development ( Continued on page 2 ) BUREAU MANAK OF BHAVAN, INDIAN 9 BAMADUR STANDARDS SHAH ZAFAR MARG 110002 NEW DELHI IS : 6058- 1970 ( Cantinusdffom page 1. ) Representing India Automobile & Ancillary Association, Bombay ( Ex-oficicio&fentber) Members SHRI D. D. TALWAL& All Industries SRRI R. M. KHALA~KAR ( Alternate ) SHRI D. DAS GUPTA, Director General Director ( Chem ) Secretaries Deputy Director ( Chem ), BIS SRRI SATISH CHANDER Assistant Director ( Chem ), BIS SHRI N. R. SRINIVASAN Medical Convener Rubber Goods Subcommittee, CDC 6 : 7 SHRI B. H. DALAL Members Ministry of Defence ( DGI ) ' SRRI G. C. CRAKRAVARTI ( Alternate to Shri B. H. Dalal ) DR B. B. BHATIA The Alkali & Chemical Corporation of India Ltd, Calcutta SHRI D. K. CHATTERJEE ( Alternate ) DR M. L. BEAUMIK National Rubber Manufacturers Ltd, Calcutta SHRI D. BOSE Bengal Waterproof Works ( 1940 ) Ltd, Calcutta SHRI A. Boss ( Alternate ) SHRI S. K. BOSE National Test House, Calcutta SRRI S. P. MULLICK ( Alternate ) EXECUTIVE SECRETARY. FAMILY Family Planning Association of India, Bombay PLAN~INQ ASSOCIATIONOF INDIA, BOMBAY DR B. M. L. KAPUR All India Institute of Medical Sciences, New Delhi SHRI P. C. KAPUR Directorate General of Health Services, New Delhi SHRI S. V. LATHIA Lathia Rubber Manufacturing Co Pvt Ltd, Bombay SHRIS.C.b'fOHAN Small Scale Latex Products Association, New Delhi SHRI R. K. DAAWAN ( Alternate ) London Rubber Co ( India ) Ltd, Madras SHRI S. W. NEWMAN SHRI S. A. PASRA ( Alternate) SHRI MANUBHAI M. PATEL Rubber Industries Pvt Ltd, Bombay SRRI K. C. SHAH ( Alternate ) SERI M. N. PATRAK Associated Rubber Industries Ltd, Bhavnagar SHRI J. C. SHAH ( Alternate ) SRRIV.D.PENDSE Swastik Rubber Products Ltd, Poona SHRI D. D. TALWALKAR ( Alternate ) SHRI P. S. RAMACRANDRAN Directorate General of Health Services, New Delhi DR S. S. GOTHASRAR ( Alternate ) Directorate General of Technical Development DR N. V. C. RAO SHRI G. R. INAMDAR ( &637U?te) Directorate General of Armed Forces Medical MAJ V. P. SET~I Services 2 IS:6058-1970 Indian Standard SPECIFICATION FOR RUBBER COMPONENTS FOR TRANSFUSION FLUID BOTTLES 0. 0.1This FOREWORD Indian Standard was adopted by the Indian StandardsInstitution on 3 December 1970, after the draft finalized by the Rubber Products Sectional Committee had been approved by the Chemical Division Council. 0.2 This standard prescribes the requirements for all the rubber components intended for use with the transfusion bottles specified in IS : 3423In the preparation of this standard assistance has been derived 1965*. from Defence Specification No. IND/MED/TC 2465 and the `IS0 Draft Proposal for transfusion equipment for medical use'. 0.3 It is need!ess to emphasize the importance of sterilization of the rubber components before use. In the case of transfusion tubing, the practice of thorough rinsing in cold water immediately after use to prevent blood from drying in the lumen shall be rigidly enforced. Effective cleaning may be accomplished by immersing the tubing in a large basin containing a O-5 percent solution of sodium hydroxide or 5 percent sodium carbonate and boiling for 15 minutes. The tubing should be boiled slowly in the solution to avoid the formation of air pockets, or better yet, the alkali solution should be circulated slowly through the tubing during the period of boiling. A large irrigating syringe may be used for this purpose or a reservoir of the alkali solution may be attached to a ring stand above the basin, connected to the tubing, and the solution slowly trickled through the lumen. After cleaning, the tubing should be rinsed with freshly distilled water until all traces of alkali have been removed. 0.4 Rubber tends to deteriorate with age. However, it is essential that components used for the transfusion fluid bottles maintain their quality for sufficient length of time; otherwise the contents will get spoiled and would become unfit for use. In Appendix A attention is drawn to simple precautions aimed at maintaining quality after the rubber components have left the manufacturer's works. 0.5 At present, most of the rubber laboratories in this country have no facilities to carry out test for toxicity and test for detecting inhibitory ___ *Specification for glass containers for transfusion fluids. 3 IS:6058- 1970 However, substances in the rubber tubings. methods given in Appendix B and Appendix where facilities are available, C may be followed. which call for agreement requirement of this calculated, expressin accordance with in the rounded off in this standard. 0.6 This standard contains clauses 4.1 and 6.3.5 between the purchaser and the supplier. 0.7 For the purpose of deciding whether a particular standard is complied with, the final value, observed or ing the result of a test or analysis, shall be rounded off IS : 2-1960*. The number of significant places retained value should be the same as that of the specified value 1. SCOPE 1.1 This specification for rubber 1965t. components prescribes the requirements and the methods of tests for transfusion fluid bottles conforming to IS : 3423- 2. COMPONENTS 2.1 This standard covers the following rubber components: bottle; or semi- a) Cap screw disc for blood transfusion b) Rubber bung with one, two or three holes ( perforated perforated ) and with or without flange; and C) Rubber tubing. 3. REQUIREMENTS 3.1 General - The components shall be made from natural or synthetic The material shall not contain substances having undesirable rubber. effect upon the contents or harmful effect upon the patient receiving the contents. 3.2 Bung and Disc for Cap Screw 3.2.1 Design - The design of the closure and material from which it is made shall be such that the closure is easy to clean and makes an air-tight seal when fitted to the transfusion bottle. 3.2.2 &fate&al - The &sure shall be made of a self-sealing elastomeric material such that, when aged for 168 h at 70°C and fitted to a transfusion bottle, it shall withstand a temperature of -40°C and the temperatures encountered during sterilization by autoclaving in saturated steam at 121"f 1°C for 1 h, without impairing its function under conditions of normal use. *Rules for rounding off numerical values ( rcuised ). tspecification for glass containers for transfusion fluids. 4 IS : 6058-1970 3.2.3 Sealing Test ageing for 168 h at 70°C and sterilizing as in 3.2.2 the closure is capable of maintaining airtightness of the container at room temperature at a pressure of 200 mm of mercury below the prevailing atmospheric pressure for 72 h, after it has been pierced with a non-coring needle of 2*4mm external diameter and the needle has been withdrawn. 3.2.3.1 The design and material of the closure shall be such that after 3.2.3.2 The closure shall not show any sign of leakage when the bottle is inverted immediately after it has been filled with fluid, the piercing needle has been withdrawn and the surface of the closure has been wiped clean. NOTE - Closures which pass the above tests will not necessarily prevent from reaching the interior of a container. The risk of bacterial contamination be avoided by taking other suitable precautions. bacteria should 3.2.4 Resistance to Water-Separate portions of the material shall be treated with distilled water in accordance with methods 1 and 2 described in Appendix D. In each case, the water shall not acquire any turbidity, colour, objectionable taste or smell. The PH of the water extract shall be 7.0 to 8-O when tested according to D-2. 3.2.5 Resistance to Chemicals -The material shall be suitable for use in contact with blood and blood products and shall conform to the requirements of chemical resistance to chemicals prescribed in Appendix E. 3.2.6 Dimensions have a diameter 3.2.6.1 Disc for cap screw-The rubber disc shall of 36.0 to 36.5 mm and thickness shall be 4-O&0*3 mm. 3.2.6.2 Bung-The bung shall have an overall height of 15 to 20 mm and thickness of the flange shall be 4.0 f 0.3 mm. The bottom portion of the bung shall be slightly tapered to facilitate insertion of the bung into the bottle. The bungs shall have semi-perforated hole(s) having a diameter of 3 to 5 mm either at the top or at the bottom of the bung. The thickness of the rubber (unperforated portion) at the holes shall be 3 f 0.5 mm. In case of a bung having semi-perforated hole(s) at the bottom, such hole(s) shall be indicated by embossing a circle at the corresponding position(s) at the top of the bung to help detection of position of the hole(s) when the bung is fitted to the blood transfusion bottle. 3.2.1 Physical Requirements and disc shall be 4045 IRHD after ageing and 3.2.7.X Hardness - Hardness of the bung IRHD and it shall not differ by more than f5 heat resistance test specified in 3.3.2. 5 IS I 6058 - 1970 3.2.7.2 Tensile strength and elongation at break - The tensile strength and elongation at break of the material used for the disc and bung shall be minimum 105 kg/cm2 and 400 percent respectively, and after ageing and heat resistance as in 3.2.2 it shall not vary from the original value by more than 2:: percent for tensile strength and +iz percent for elongation at break. 3.2.7.3 percent. 3.3 Rubber The material shall have a compression set of maximum 45 Tubings 3.3.1 Material-The tubing made of natural rubber or synthetic material shall be transparent or sufficiently translucent for the passage of The material shall not contain bubbles of air to be readily detected. substances having undesirable effects upon the contents or harmful effects upon the patient receiving the contents: NOTE window -The use of opaque rubber tubing necessitates the introduction in the blood collection assembly about 5 to 6 cm from the blood taking of the needle. 3.3.2 Heat Sterilization Test - When subjected to ageing and sterilization test as mentioned in Appendix F, the tubing shall remain elastic, shall not' become tacky or hard and effect its serviceability; it shall maintain a firm Slight change in colour of the tubing is grip on the glass tubing. permissible. 3.3.3 Resistance described in 3.2.4. 3.3.4 Resistance described in 3.2.5. 3.3.5 tubing Dimensions to Water -The to Chemicals -The tubing shall withstand the test the as test tubing shall withstand 3.3.5.1 .Nominal diameter and thickness shall be as follows: Nominal a> b) Internal Diameter, mm 3.0 f 5.0 f 0.3 0.5 The dimensions Nominal for the rubber Wall Thickness, mm 1.5 f 3.0 4 0.2 0.3 shall ,be 3.3.5.2 Length - Unless otherwise specified, supplied in coils of not less than 10 m lengths. 3.3.6 and Physical Requirements the tubing 3.3.6.1 finsile strength and elongation at breakThe tensile strength elongation at break of the tubing shall be at least 105 kgf/cm2 and Q IS : 6058- 1970 400 percent respectively, and after oven or heat sterilization according it shall not vary from the original tensile strength and elongation at ageing at 70" f 1°C for 168 h in an airto the method prescribed in Appendix F, value by more than _ti z percent for both break. 3.3.6.2 Tension set - The tension set after 200 percent elongation for 10 minutes followed by a recovery period of another 10 minutes shall not exceed 10 percent. 3.3.7 The tubing shall be free from harmful contamination metals, namely, arsenic, copper, iron and manganese. of heavy 3.3.7.1 The concentration of each of the metallic impurities in 3.3.7 shall not exceed 5 ppm in the sterile pyrogen-free isotonic saline solution prescribed in 6.4. 4. PACKING AND MARKING cartons or as and The material may be packed in cardboard agreed to between the purchaser and the supplier. 4.2 Marking - Each carton indelibly marked with: a) nomenclature b) the manufacturer's 4.2.1 The material may containin, 0 the material and size; 4.1 Packing- shall be plainly of the material name or trade-mark, also be ma.rked if any, or both; the and c) the month and year of manufacture. with Standard Mark. 4.2.2 The use of the Standard Mark is governed by the provisions of the Bureau of Indian Standards Act, 1986 and the Rules and Regulations made thereunder. The details of conditions under which the licence for the use of Standard Mark may be granted to manufacturers or producers may be obtained from the Bureau of Indian Standards. 5. SAMPLING 5.1 Representative the method samples for various tests shall be drawn according and scale of sampling given in Appendix G. to 6. TEST METHODS 6.1 Unless otherwise agreed to between all tests shall be carried out within three the material by the purchaser. 7 the purchaser and the supplier, months of the date of receipt of IS : 6058 - 1970 6.2 Test Pieces - Wherever possible the specified test pieces shall be cut from the finished article. Where this is impracticable the manufacturer shall supply two sheets of vulcanizates 300 x 300 x 3 mm and 150 x 150 x 6 mm ( prepared from the same batch and vulcanized to the same degree and in the same manner as the consignment concerned ) from which the necessary test pieces shall be prepared. 6.3 Physical Properties 6.3.1 Tensile Strength and Elongation at Break - Carry out the test on dumb-bell test pieces cut out of the article or press cured slab in accordance with the method prescribed in IS : 3400 ( Part I )-1965*. 6.3.2 1965T. Hardness Carry out test in accordance with IS : 3400 (Part II)- 6.3.3 Accelerated Ageing - Subject dumb-bell test pieces to ageing at 70" & 1°C for 168 h in an air-oven or a cell type oven in accordance with the method prescribed in IS : 3400 ( Part IV ) -19651. 6.3.4 Compression Set 6.3.4.1 Test specimen - Cut out a test specimen 6 mm in thickness by making a transverse cut at suitable distance from the top surface of the piece, if necessary. The flange of the bung shall be trimmed off. In the case of disc for cap screw, a thickness of 6 to 10 mm small be built up by plying together layers of materials of approximately equal thickness. 6.3.4.2 Procedure - The specimen shall have the flat faces parallel to each other. It shall be compressed to 75 percent of its original thickness between two flat steel plates of a suitable compression device ( preheated The device with the compressed to a temperature of 125" f 1°C ). specimen shall be kept for 28 h in an autoclave containing saturated steam at a pressure of 1.4 kg/cmg. Every effort shall be made to remove all the air from the autoclave before the test pressure is reached. At the end of the autoclaving period, the compression device shall be removed from autoclave, the specimen taken out and allowed to cool and recover for a period of 30 minutes in an atmosphere maintained at a temperature of 27" -& 2°C. The thickness of the specimen shall then be measured and *Methods of test for vulcanized rubbers: Part I Tensile stress-strain properties. TM&hods of test for vulcanized rubbers: Part II Hardness. $Methods of test for vulcanized rubbers: Part IV Accelerated agcing. 8 IS : 6058 - 1970 the compression set calculated Compression where t, = original tz = thickness thickness of specimen, after recovery, and under compression. of specimen of specimen in accordance set, percent = with the following 100 X $14p 0 1 formula: t, = thickness 6.3.5 Tension Set - ( `The Indian Standard method of test for measuring Till such time this Method is published, tension set' is under preparation. method as agreed to between the purchaser and the supplier shall be followed ) . 6.4 Test for Metallic Contamination in Tubing 6.4.1 Preparatioll of Test Solution - Pass 40-ml portions of sterile pyrogen- free isotonic saline solution containing 9 g of sodium chloride per litre at room temperature through a metre-length tubing at a flow rate of approxiMake up the solution mately 10 ml per minute and collect the efluent. to 250 ml. 6.4.2 Test for Arsenic- Carry out the test for arsenic as prescribed in IS : 208%1962* with 10 ml of the solution, using for comparison a stain * obtained with 0.005 mg of arsenic trioxide ( As,03 ). 6.4.3 Test for Co#er, l\%nganese and Iron - Carry out tests for copper, manganese and iron as prescribed in NR : 4, NR : 5 and NR : 6 of IS : 3660 ( Part I )-19661_ respectively with test solutions, prepared according to 6.4.1. 6.4.4 Test for Heazp Metals in accordance with the method Heavy metal contamination given in Appendix H. shall be tested APPENDIX A ( Clause 0.4 ) NOTES ON STORAGE OF RUBBER COMPONENTS TRANSFUSION FLUID BOTTLES FOR A-l. Rubber tends to deteriorate with age. Rubber components for transfusion fluid bottles should be packaged in a way which normally will protect them during storage. Never the less, they shouldnot be kept in stock The articles should longer than is necessary, especially in warm climates. __`Modilicd ~Xfethotls Gutzeit method of test for arsenic. of lest for natural rubber, Part I. 9 IS : 6058 - 1970 be stored in a cool place and should be kept in containers such that the As soon as any contents will not be subjected to mechanical damage. component shows any deterioration of the characteristics of the rubber, it should be destroyed. The articles should not at any time be allowed to come into contact with oil-based antiseptic, phenols and their derivatives, petroleum-based grease, petroleum spirit, paraffin ( kerosene ) and other related organic products since all these materials are extremely harmful to rubber. APPENDIX ( Clause 0.5 ) TEST FOR TOXICITY B B-l. PROCEDURE B-l.1 Fill a 150-mm Iength of tubing as completely as practicable with sterile pyrogen-free isotonic saline solution containing 9 g of sodium chloride per litre, clamp the ends securely to retain the solution anrl Heat the water and maintain immerse the filled set completely in water. at not less than 85°C for 1 h. Drain the contents of the tubing. Inject intravenously 0.5 ml of the solution so prepared into each of five healthy mice weighing 20 f 3 g each. At the end of 4, 24 and 48 h examine the animals for discernible symptoms of toxicity. If any of the animals show gross signs of toxicity or die, repeat the test with five unused mice weighing 20 f 3 g each. B-1.1.1 The test shall be deemed to be satisfied if all the animals survive for 48 h. APPENDIX ( Clause 0.5 ) TEST FOR INHIBITORY C-l. PROCEDURE C IN RUBBER SUBSTANCES C-l.1 Heavily inoculate a blood-agar plate over the entire surface with a young broth culture of streptococcus pyogens. The blood-agar plate shall consist of nutrient agar containing 10 percent of horse blood in a petri dish. Select 5-mm length of representative sample of the tubing. Wash the tubing sample in distilled water, then sterilize them by autoclaving in 10 I& . 6058 - 19'70 distilled water for 30 minutes at 120°C. Rinse twice in sterile distilled Place the samples on the blood-agar surface applying water and dry. slight pressure observing the usual asceptic precautions with a minimum Incubate the whole at 37°C for distance oF20 mm between each item. 24 to 48 h. In the absence of inhibitory substances, the growth of str@ococcus pyogens right to the edge of the sample, is evidensed by haemolysis In the presence of inhibitory substances, there 1s a of the red blood cells. ring of unhaemolysed blood without bacterial growth around the sample. APPENDIX D ( Clause 3.2.4 ) TEST FOR RESISTANCE D-l. D-l.1 METHOD 1 TO DISTILLED WATER Cut the rubber into small pieces of approximately 3-mm cube size and keep in 20 times its weight of distilled water for 24 hours at a Examine the water for any colour or objectemperature of 27" f 2°C. tionable taste. D-Z. METHOD 2 D-2.1 Cut the rubber into small pieces of approximately 3-mm' cube size and keep in 20 times its weight of distilled water contained in a chemically resistant glass flask. Fit the flask with a water-cooled reflux condenser with a ground glass connection. Heat the water to boiling point and continue boiling for one hour. Cool the flask with its contents to room temperature. Examine the water for any colour or objectionable taste, Test the PH of the water extract with a PH meter fitted with glass electrodes. APPENDIX ( Clause 3.2.5 ) TEST FOR RESISTANCE E-l. E-l.1 REAGENTS Concentrated Dextrose-Sodium E TO CHEMICALS together equal volumes of 5 percent solution percent ( W/U) solution of sodium chloride. Chloride Solution - Mix ( w/u ) of dextrose with 0.9 Mix together ( w/u) solution E-l.2 Dilute Dextrose-Sodium Chloride Solution 2.5 percent ( W/V) solution of dextrose with O-45 percent of sodium chloride. II IS : 6058 - 1970 E-l.3 E-l.4 E-l.5 E-l.6 Dextrose Sodium Sodium Sodium Solution Sulphate Citrate 5 percent ( W/U ). 4.2 percent 3 percent ( w/v ). Solution Solution - ( W/U ). Bicarbonate 14 percent ( w/u ) . E-2. PROCEDURE E-2.1 Method 1 - Cut the rubber article into small pieces of approximately 3-mm cube size and keep in 20 times its weight of the specified solution ( g_iven in E-l.1 to E-l.6 ) for 3 h at a temperature of 27" f 2°C m a chemically resistant glass flask. During the period, thoroughly shake the flask at intervals of 10 minutes, the duration of On completion of the test, examine shaking each time being one minute. the rubber and the solution for any apparent changes resulting from the treatment. E-2.2 Method 2 - Cut the rubber article into small pieces of approximately 3-mm cube size and keep in 20 times its weight of the specified solution ( given in E-l.1 to E-l.6 ) and autoclave for 20 minutes at 1.4 kgf/cm2 steam pressure. On completion of the test, examine the rubber and the solution for any apparent changes resulting from the treatment. E-3. RESULTS E-3.1 Bung and Tubing - When tested according to the method prescribed in E-2.1 in solution prescribed in E-l.1 to E-1.6, no visual change shall occur either in the rubber or in the solutions E-1.1, E-l.2 and E-1.3; no visual change shall normally occur in solutions E-1.4, E-I.5 and E-1.6, but in case a very faint turbidity ( to the extent of slight translusence ) occurs, the rubber sample may still be considered to have passed the test; no precipitate shall be formed in any of the six solutions. E-3.2 Disc E-3.2.1 When tested according to the method proscribed in E-2.1 in the solution prescribed in E-1.6, no visual change shall occur either in the rubber or in the solution and no precipitate shall be formed in the solution. E-3.2.2 When tested according to the method prescribed in C-2.2 in solutions E-I.1 to E-1.6, no visual change shall occur either in the rubber or in solutions E-1.1, E-l.2 and E-1.3; no visual change shall normally occur in solutions E-1.4, E-1.5 and E-1.6, but in case, a very faint turbidity ( to the extent of slight translusence ) occurs, the rubber sample may still be considered to have passed the test; no precipitate shall be formed in any of the solutions. 12 IS : 6058 - 1970 APPENDIX F ( Clauses 3.3.2 and 3.3.6.1 ) HEAT STERILIZATION F-1. PROCEDURE Loosely warp dumb-bell test pieces prepared for mechanical tests in surgical gauze in such a manner that all rubber surfaces are separated from one another, and subject to heat-treatment at 134'?$"C for 3 minutes in a pressure steam sterilizer. On the completion of the test period release the steam pressure. Take out the rubber test pieces from the gauze and allow to cool to normal room temperature as quickly as possible. Repeat the process after a lapse of at least 20 minutes but as soon as possible thereafter until three heatings have been made. After completion of the heat treatment, allow the test pieces to cool at room temperature for 24 h and then test for tensile strength and elongation at break. TEST F-l.1 APPENDIX ( Clause5.1 ) SAMPLING G-l. SCALE OF SAMPLING G-l.1 LotIn any consignment, G OF BUNG, DISC AND RUBBER TUBING all the bungs, discs or tubings of the same type and manufactured by the same firm under similar conditions of manufacture shall be separated in groups of 1 000 number, and each shall constitute a lot. G-l.2 Test `for the determination of the conformity of the lot to the requirements of this specification shall be carried out for each lot separately. The number of discs, bungs or tubings, to be selected for carrying out the test for visual and dimensional characteristics shall be in accordance with co1 1 and 2 of Table 1. TABLE LOT 1 SCALE OF SAMPLING PERMISSIBLE ~%J?~BEROF DEBECTIVE ITEMS (3) 0 ; No. OP ITEMS TO BE SIZE No. TO BE SELECTED SELECTED FOR DESTRUCTION TYPE OF CHARACTERISTICS (4) 2 3 .N (1) 501 to 1000 1001 to 3 000 3001 to 5000 (9, up to 500 10 2 50 2 5" 13 IS : 6058 - 1970 In order to These items shall be selected at random from the lot. ensure the randomness of selection, a random number table as agreed to between the purchaser and the supplier shall be used. In case such a table is not available the following procedure shall be adopted: G-l.3 Starting from an item in the lot, count them as 1, 2, 3 up to r and so on in one order, where Y is the integral part of N/n (see G-l.2 ). Every rth item thus counted shall be withdrawn to give the sample for test. APPENDIX ( Clause 6.4.4 ) TEST FOR HEAVY H-O. OUTLINE OF METHOD H METALS H-0.1 The solution is prepared as in 6.4.1 and tested with aqueous hydrogen sulphide solution. The resultant brown colour, if any, is matched with that produced with a standard lead solution. H-1. APPARATUS H-l.1 H-2. H-2.1 H-2.2 Nessler Tubes - 100 ml capacity. REAGENTS Citric Acid Nitric Acid Concektrated H-2.3 Bromophenol Blue Indicator - Dissolve 0.1 g of bromophenol blue in 100 ml of rectified spirit ( conforming to IS : 323-1959*). II-2.4 H-2.5 H-2.6 Copper Hydrogen Dilute Sulphate Sulphide Acid gas from Kipp's apparatus. approximately I percent. 1 volume of liquid ammonia blue in Nitric H-2.7 Ammonium Hydroxide - Dilute (sp gr 0.92 ) with 10 volumes of water. H-2.8 Thymol Blue IndicatorDissolve 0'1 g of thymol 100 ml of rectified spirit ( conforming to IS : 323-1959* ). *Specification for rectified spirit ( revised ). 14 IS : 6058 - 1970 H-2.9 H-2.10 tion. Potassium Hydrogen Cyanide Solution 10 percent ( w/v). saturated soluin of of be Sulphide Solution,- freshly prepared H-2.11 Standard Lead SolutionDissolve 0.800 g of lead nitrate water and make up the solution to exactly 1 000 ml. Pipette out 10 ml the solution and dilute it again with water to 1 000 ml. One millilitre the final solution contains 0.005 ml of lead ( Ph). The solution shall freshly prepared. H-3. PROCEDURE H-3.1 Prepare a solution as in 6.4.1 but make up the volume to 100 ml. Transfer the solution to a beaker. Add 5 g of citric acid and adjust PH to 3.0 to 3.4 by adding ammonium hydroxide to give a yellow purple colour with bromophenol blue indicator. Add about 5 g of copper sulphate to act as coprecipitant. Precipitate sulphides by passing hydrogen sulphide until solution is saturated. Dissolve the sulphides, without previous washing with 5 ml of hot dilute nitric acid, drawing solution through the filter into the original flask; wash with hot water, and collect the washing along with the solution in nitric acid. Boil to remove sulphuretted hydrogen. Concentrate the content to about 75 ml. Add 3 to 4 ml of concentrated nitric acid, make ammoniacal to bring flH between 8.5 and IO.0 (bluishgreen to blue towards drop of thymol blue indicator ) and add 5 ml of potassium cyanide solution. Transfer to a Nessler tube, add IO ml of hydrogen sulphide solution, dilute to the mark and shake. Carry out a a control test using 1 ml of standard lead solution and the same quantities of other reagents as used in test with the material. H-3.2 The test solution shall be taken as not having exceeded the limit prescribed if the intensity of colour produced in the test with the material is not greater than that produced in the control test. 15 BUREAU OF INDIAN STANDARDS Heedquartem Manak Bhavan. 9 Bahadur Shah Zafar Marg. NEW DELHI 110002 Telephones: 323 0131, 323 3375, 323 9402 Fax :91113234062, 91113239399, 91113239362 Telegrams : Manaksanstha (Common to all Offices) Centrsl Laboratory: Plot No. 20/9, Site IV, Sahibabad Regional Central `Eastern Northern Southern Otfices: Industrial Area, SAHIBABAD 201010 Telephone 6-77 00 32 : Manak Bhavan, 9 Bahadur Shah Zafar Marg, NEW DELHI 110002 : l/l4 CIT Scheme VII M. V.I.P. Road, Maniktola, CALCUTTA700054 : SC0 335-336, Sector 34-A, CHANDIGARH 160022 323 76 17 337 86 62 60 38 43 235 23 15 632 92 95 : C.I.T. Campus, IV Cross Road, CHENNAI 600113 TWestern : Manakataya, E9 Behind Mar01 Telephone Exchange, Andheri (East), MUMBAI 400093 Branch Offices: `Pushpak', Nurmohamed Shaikh Marg, Khanpur, AHMEDABAD 380001 550 13 48 839 49 55 55 40 21 40 36 27 21 01 41 8-28 88 01 8-71 19 96 54 11 37 20 10 83 37 29 25 21 68 76 23 89 23 26 23 05 6 21 i7 52'51 71 32 36 35 SPeenya Industrial Area, 1st Stage, Bangatore BANGALORE 560058 Gangotri `Kalaikathir Complex, 5th Floor, Bhadbhada - Tumkur Road, Road, T. T. Nagar. BHOPAL 462063 751001 641037 121001 Plot No. 62-63, Unit VI. Ganga Nagar. BHUBANESHWAR Buildings, 679 Avinashi Road, COIMBATORE Road, FARIDABAD 201001 Plot No. 43. Sector 16 A, Mathura Savitri Complex, 58-58C, 116 G.T. Road, GHAZIABAD 53/5 Ward No. 29, R. G. Barua Road, 5th By-lane, GUWAHATI 781003 L. N. Gupta Marg. Nampally Marg, C-Scheme, Nagar, KANPUR Station Road, HYDERABAD 206005 500001 E-52, Chitaranjan JAIPUR 302001 117/418 B. Sarvodaya Seth Bhawan, 2nd Floor, Behind Leela Cinema, Naval Kishore Road, LUCKNOW 226001 Patliputra Industrial Estate, PATNA 800013 P. 0. Palsyam, 695034 T. C. No. 14/1421, University THIRUVANANTHAPURAM NIT Building, Second Institution of Engineers Floor, Gokulpat Market, NAGPUR 440010 ( India ) Building, 1332 Shivaji Nagar, PUNE 411005 Approach, f? 0. Princep Street, `Sales Office is at 5 Chowringhee CALCUTTA 700072 TSales Office is at Novelty 27 10 85 Grant Road, MUMBAI 400007 309 65 28 222 39 71 Square, Chambers, *Sales Office is at `F' Block, Unity Building, Narashimaraja BANGALORE 560002 Printed at New India Printing Press, Khurja, India AMENDMENT NO. 1 TO OCTOBER 1978 IS : 6058-1970 SPECIFICATION FOR RUBBER COMPONENTS FOR TRANSFUSION FLUID BOTTLES Alterations ( Pages 3 and 4, clause 0.5 ) clause: Substitute the following for the existing `0.5 At present, most of the rubber laboratories in this country have no facilities for carrying out tests for toxicity and for detecting inhibitory substances in the rubber components. However, where facilities are available, methods given in Appendices B and C may be followed.' ( Page 9, clauscc 6.4 and 6.4.1 ) existing clauses: `6.4 Test for Metallic Contamination Substitute the following for the in Components 6.4.1 Prcjwration of Test Solution isotonic 6.4.1.1 Tubing - Pass 40-ml portions Of sterile pyrogen-free saline solution containing 9 g of sodium chloride per litre at room temperature through a metre-length tubing at a flow rate of approximately 10 ml per minute and collect the effluent. Make up the solution to 250 ml. 6.4.1.2 Bungs and discs - Immerse 5 g of the sample cut to small pieces in 25 ml of sterile pyrogen-free isotonic saline solution containing 9 g of the sodium chloride per litre at room temperature for about 5 minutes. Collect the solution in a suitable container and make up the solution to 250 ml.' ( Page 10, Appendix B ) appendix: Substitute the following for the existing `APPENDiX ( czause 0.5 ) TEST FOR TOXICITY B-l. PREPARATION OF EXTRACT B B-l.1 Tubing - Fill specimens of tubing, each 150 mm in length, as completely as practicable with sterile pyrogen-free isotonic saline solution containing 9 g of sodium chloride per litre. Clamp the ends 1 securely to retain the solution and immerse the filled set completely in Heat the water and maintain it at 85°C for 1 hour. Collect the water. contents of the tubings in a suitable contiiner and cool to room temperature. 1 g of the sample cut to small B-l.2 Bungs and Discs - Immerse pieces ( each approximately 3 mm cube in size ) in 5 ml of sterile pyrogen-free isotonic saline solution containing 9 g of sodium chloride per litre, in a test tube. Close the test tube with a suitable stopper and immerse the same in water with the closed end above the surface of Heat the water and maintain it at not less than 85°C for 1 hour. water. Collect the solution in a suitable container and cool to room temperature. B-2. PROCEDURE B-2.1 Inject intravenously the solution prepared aq described in B-l, into each of five healthy mice weighing 20 -& 3 g each. At the end of 4,24 and 48 hours examine the animals for discernible symptoms of toxicity. If any of the animals show gross signs of toxicity or die, repeat the test with five unused mice weighing 20 & 3 g each. B-2.2 The test shall be deemed for 48 hours.' to be satisfied if all the animals survive ( Puges 10 and 11, clause C-1.1, fines 4 LO6 ) - Substitute ` Cut 5 mm long strips of convenient width and thickness from the sample of rubber component. Wash the strips in distilled water, then sterilize them by autoclaving in distilled water for 30 minutes at 120°C' fog `Select 5-mm length of representative sample of the tubing. Wash the tubing sample in distilled water, then sterilize them by autoclaving in distilled water for 30 minutes at 120°C. ' Addendum after (Page 6, 3.2.7.3: clause 3.2.7.3) Add the following new clauses of `3.2.8 The components shall be free from harmful contamination heavy metals, namely, arsenic, copper, iron and manganese. 3.2.8.1 The concentration of each of the metallic impurities in 3.2.8 shall not exceed 5 ppm in sterile pyrogen-free isotonic saline solution prescribed in 6.4.' (PCDC 13) 2 Pnnted at New India hntmg Press, Khujs, India